Recruiting

Continuous vs. Bolus Protein

Sponsor:

University of British Columbia

Code:

NCT06721923

Conditions

Critical Illness

Pediatric Intensive Care

Enteral Nutrition Therapy

Dietary Protein

Eligibility Criteria

Sex: All

Age: 1 - 11

Healthy Volunteers: Not accepted

Interventions

Dietary protein

Study Details

Brief summary:

The goal of this intervention study is to evaluate the difference in nutrition status markers (weight and muscle mass) when giving dietary protein by continuous or bolus delivery in critically ill children ages 1-11y.

The main questions it aims to answer are:

Primary: Bolus protein delivery will lessen the decline in mid-upper arm circumference (MUAC) z-score by 0.5 standard deviation in critically ill children aged 1-11y after 1wk. Ultrasound will correlate to MUAC.

Secondary: Bolus protein delivery will provide more (grams per day) than when provided continuously, therefore it is more likely to meet the minimum estimated needs.

Participants will have daily nutrition intake data collected, and undergo body composition measures (weight, MUAC and ultrasound of the upper thigh muscle) at day of enrollment, and MUAC/Ultrasound on follow up days 3, 5, 7 and 14 after the intervention started.

Conditions

Critical Illness

Pediatric Intensive Care

Enteral Nutrition Therapy

Dietary Protein

Study ID

NCT06721923

Start date

Feb 13, 2024

Status verified date

Feb, 2026

Completion date

Dec 12, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 11

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children admitted to PICU over 1 year of age and younger than 11 years of life
  • Expected to remain in the pediatric intensive care unit for longer than 72 hours
  • Receiving standard pediatric formula via NGT/OGT/GT

Exclusion Criteria:

  • Neuromuscular condition such as muscular dystrophy
  • Admitted with home prescription for high dose steroids, receives growth hormone or insulin
  • Enteral nutrition is contraindicated or if nutrition requirements are partially/fully met by parenteral nutrition
  • Formula delivered into the small bowel (duodenum/jejunum, NJT/GJ)
  • Those who require a highly specialized diet (E.g., large burns or metabolic diseases)
  • Patients with a cow's milk protein allergy cannot safely receive a whey-based protein supplement

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Continuous protein

Continuous protein arm will have dietary protein supplement mixed into the enteral formula product to be provided around the clock without break.

experimental: Bolus protein

Bolus protein arm will provide protein powder mixed with water every 4h through syringe. This will be in addition to continuous enteral formula feeding which remains standard of care.

Interventions

Dietary protein

Beneprotein powder, a whey-based supplement, will be used in both arms. Intervention dose will be 1g/kg of dietary protein (or 1.2g/kg of the powder), provided to both arms with different modes of delivery.

Primary outcome measure

  • Mid-upper arm circumference [ Time Frame: admission, 7 and 14 days ]

Central Contacts and Locations

Central contacts

Kaitlin A Berris, BSc

604-875-2000kaitlin.berris@bcchr.ca

Rajavel Elango, PhD

604-875-2000relango@bcchr.ubc.ca

Locations

BC Childrens Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Kaitlin A Berris, BSc

604-875-2000kaitlin.berris@bcchr.ca

Principal Investigator:

Rajavel Elango, PhD

More Information

Sponsor

University of British Columbia

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • enteral nutrition
  • pediatric critical care
  • bolus protein delivery
  • continuous protein delivery
  • ultrasound
  • mid-upper arm circumference

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-02-12.